This year’s conference is designed to address the most pressing challenges and opportunities facing the industry. The conference opens with “Aseptic 101”—a perfect primer for newcomers and a valuable refresher for veterans.
Monday, 23 March, will kick off with noted regulatory keynote speakers, past and present—namely with Brooke Higgins, Senior Vice President for Regulatory Compliance with Eliquent Life Sciences, exploring the critical role of public health in aseptic processing and Rick Freidman, Deputy Director of the Office of Manufacturing Quality with the US Food and Drug Administration (US FDA)/CDER reflecting on his many years of US FDA service and the evolution of sterile manufacturing over the past several decades.
Following the keynotes, the conference has in-depth tracks on day one for attendees to choose from. There will be seven distinct speaker sessions on advanced therapy medicinal products (ATMPs), and a roundtable to end the day, with topics ranging from advancing the business case through technological solutions (e.g., maximizing dose volumes and cost effectiveness) to utilizing digital twins in ATMP manufacturing.
A variety of case studies and presentations on managing Annex 1 compliance will also take place on the first day, highlighted by a session from Franck Bure of Roche/Genentech on global challenges Annex 1 presented to his organization. The third set of sessions consists of discussions on isolator design in the morning—including virtual reality implementation and gloveless designs. Speakers from component manufacturers like Gerresheimer, West Pharmaceutical Services, and Stevanato Group comprise an afternoon session with discussion on the importance of component quality in the overall aseptic manufacturing process.
The world of 503B compounding pharmaceuticals came into focus this past year as some of these firms were filling gaps with innovators’ products falling on the US FDA drug shortage list. Tuesday, 24 March, will include an industry panel of experts from the compounding pharmaceutical producers’ panel on the latest regulations and advancements in 503B production.
The second day continues with keynote addresses, followed by concurrent morning sessions, with a deep dive into facility design and delivery for fill/finish operations from leading producers, contract development and manufacturing organizations (CDMOs) and equipment manufacturers.
The theme of digitization runs through the Airflow Testing track sessions with a session on modeling capability. Airflow testing best practices and Annex 1 regulations related to airflow visualization will round out the Airflow Testing track.
Manufacturing radiopharmaceuticals and other high potent products comprise the other Tuesday morning concurrent sessions. The ISPE Sterile Products Processing Community of Practice will facilitate a dedicated Sterile Processing track to address the evolving landscape of regulatory expectations in aseptic processing. Recent inspections have challenged long-accepted practices, prompting manufacturers to reassess their compliance strategies. By highlighting inspection trends and sharing firsthand experiences, the sessions will foster a deeper understanding of current regulatory priorities. This will be a highly interactive session with panelists from CDMOs and leading engineering firms. Other afternoon concurrent sessions include case studies on isolator decontamination and mapping restricted access barrier systems (RABS) glove failures and sessions on lyophilization—focusing on operations and automated loading/unloading for Annex 1 compliance.
The conference concludes with regulators taking stage front and center. As is tradition with the ISPE Aseptic Conference, the regulatory panel will close the conference. Audience members have a chance to submit questions to the US FDA and MHRA panelists who will give straightforward answers. This chance to interact live with regulatory experts is reason alone to attend this conference!
There is simply no venue like the ISPE Aseptic Conference—with its cutting-edge content, expert speakers, hands-on learning through case studies on a variety of pertinent topics. This conference is paving the way for the future of aseptic manufacturing and is not to be missed.
Learn more and register today.
